EndoClot for Hemostasis and Preventing Post-procedure Bleeding After Endoscopic Mucosal Resection (EMR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhiguo Liu, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier:
NCT01496781
First received: December 19, 2011
Last updated: April 14, 2012
Last verified: April 2012
  Purpose

Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment techniques of gastrointestinal small lesions. Para-procedure bleeding is one of the common complication following EMR. Several endoscopic hemostasis methods are currently in use including metallic hemoclip. EndoClot® absorbable polysaccharide hemostat (PAPH) as a new hemostasis material was previously used for surgical hemostasis, but the therapeutic effect and safety in endoscopic application remains unknown. This randomized controlled study has been designed to compare PAPH with metallic hemoclip in their hemostatic effect of intra-procedure bleeding control and rebleeding prevention during and after EMR.


Condition Intervention
Endoscopic Hemostasis
Colonic Polyps
Procedure: Hemoclip
Procedure: EndoClot

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: EndoClotTM Absorbable Polysaccharide Hemostat in Comparison With Metallic Hemoclip for Hemostasis and Preventing Post-procedure Bleeding After Endoscopic Mucosal Resection: a Prospective, Randomized Trial

Resource links provided by NLM:


Further study details as provided by Xijing Hospital of Digestive Diseases:

Primary Outcome Measures:
  • Hemostasis rate after EMR [ Time Frame: Up to half an hour immediately after EMR procedure to ensure successful management is achieved. ] [ Designated as safety issue: No ]
    Initial hemostatsis was observed endoscopically immediately after application of hemoclip or Endoclot. Complete hemostatsis is ensured. Endoscopic combined hemostasis or emergency surgery would be applied if severe bleeding occurred and endoscopic management fails


Secondary Outcome Measures:
  • Mucosal healing after EMR [ Time Frame: up to 1 month ] [ Designated as safety issue: Yes ]
    Colonoscopy will be repeated 1 month after EMR procedure to observe if application of Endoclot will delay the musosal healing.

  • Time taken to achieve hemostasis [ Time Frame: Up to half an hour immediately after EMR procedure to ensure successful management is achieved. ] [ Designated as safety issue: No ]
    The time taken to achieve hemostasis is recorded immediately after EMR procedure to reflect the technical difficulty of hemostasis measure.

  • Rebleeding rate after EMR procedure [ Time Frame: up to 1 week ] [ Designated as safety issue: No ]
    Rebleeding rate up to 1 week was obtained by clinical manifestations such as melana; decreased hemoglobin > 20g/L; hemodynamic instability or active bleeding from mucosal defect under endoscope.

  • gastrointestinal tract obstruction [ Time Frame: up to 1 month ] [ Designated as safety issue: Yes ]
    Gastrointestinal tract obstruction has been previously reported as a possible adverse effect of hemostats, therefore it was observed in the current study.


Enrollment: 164
Study Start Date: April 2010
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EndoClot
This arm is designed to observe if the Endoclot treatment can achieve comparable hemostasis efficacy compared with hemoclip.
Procedure: EndoClot
EndoClot hemostat is applied immediately after EMR to achieve hemostasis.
Other Name: EndoClot® Absorbable Polysaccharide Hemostat (Cat# Y2007090722, Starch Medical Inc)
Active Comparator: Hemoclip
This arm is used as a control treatment group to compare with Endoclot treatment.
Procedure: Hemoclip
Hemoclip application is a standard treatment option after endoscopic mucosal resection of colonic lesion to stop and prevent post-procedure bleeding.
Other Name: metallic hemoclip (Cat# HX-610-090L, Olympus)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • consecutive cases of colorectal polyps and submucosal tumors with anticipated complete removal endoscopically by EMR.

Exclusion Criteria:

  • severe cardiovascular diseases, liver and kidney dysfunction;
  • platelet and coagulation dysfunction (PLT < 50*109/L, INR > 2);
  • cases that have taken anticoagulant drugs or non-steroidal anti-inflammatory drugs within 1 month before the procedure;
  • cases unavailable for follow-up.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01496781

Locations
China, Shaanxi
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital of Digestive Diseases
  More Information

Publications:
Responsible Party: Zhiguo Liu, Associated Professor, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier: NCT01496781     History of Changes
Other Study ID Numbers: 20111219
Study First Received: December 19, 2011
Last Updated: April 14, 2012
Health Authority: China:Xijing Hospital of Digestive Diseases

Keywords provided by Xijing Hospital of Digestive Diseases:
Endoscopic Hemostasis
metallic hemoclip
EndoClot Absorbable Polysaccharide Hemostat
Colonic Polyps

Additional relevant MeSH terms:
Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014